MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. MODIFIED KUGEL PATCH; SURGICAL MESH

Catalog Number 0115814

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Internal Organ Perforation (1987); Pain (1994); Swelling (2091)

Event Date 01/27/2017

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, no conclusion can be made as to why the issue presented.A root cause is undetermined at this time.Additional information was requested.The user facility provided additional information however reports the responses are preliminary based on their ongoing investigation.Should additional information be provided, a supplemental mdr will be submitted.As reported the sample is not available for evaluation.A review of the manufacturing records was performed and found that the lot was manufactured to specification.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

The following was reported to davol by the fda via medwatch 3500a report: note: see attached pdf of 3500a medwatch report (b)(4) and through follow up with contact.On (b)(6) 2017 the patient underwent a left incarcerated inguinal hernia repair with implant of a bard modified kugel hernia patch.Per contact the patch was soaked in antibiotic solution and then placed in the preperitoneal space via the internal ring.The straps were retracted anteriorly.Superior strap was sutured to the internal oblique muscle with 2-0 pds mattress suture.Inferior strap was sutured to the internal oblique muscle with 2-0 pds mattress suture.Excess straps were excised.As reported on (b)(6) 2017, four days post implant; the patient presented to the hospital er with testicular swelling, pain and dysuria and underwent an additional procedure.Per contact an anterior cystotomy was performed.A large piece of mesh was retrieved inside the bladder.The patch was removed completely.There was an approximate 1 cm hole identified in the bladder wall, which was closed with a running stitch of 2-0 chromic suture.

• Brand Name: MODIFIED KUGEL PATCH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6699338
• MDR Text Key: 79570918
• Report Number: 1213643-2017-00391
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030819
• UDI-Public: (01)00801741030819(17)211028(10)HUAX2001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2021
• Device Catalogue Number: 0115814
• Device Lot Number: HUAX2001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR